11 results
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19ms
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Sources: EU EUDAMED, US FDA
Boston 2910 (Boston 2910)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ceraMotion®
FDA UDI
DENTAURUM GmbH & Co.KG·J011253245200·ceraMotion® Lf Chroma Concept Incisal 1, bleach...
Truliant
FDA UDI
Exactech, Inc.·10885862556431·TRIAL, TIBIAL INSERT, CR, SLOPE+, SIZE 4.5
GP GENERAL PURPOSE DRAINAGE CATHETER; MINI-PIG DRAINAGE CATHETER; NEPHROSTOMY CATHETER; BILIARY CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Baha 5 Super Power Sound Processor
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
630G INSULIN PUMP MMT-1715K 630G BLACK MG
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·July 28, 2018
CUSTOM PAK
FDA Adverse Event
Malfunction
·ALCON - HOUSTON·Product code KYG·November 13, 2014
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE - ANDOVER·Product code MKJ·August 3, 2011
PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 58MM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code LPH·July 29, 2013
COPAN WASP/COLIBRI
FDA Adverse Event
Other
·COPAN WASP·Product code QQV·July 25, 2024
Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012